Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie
August 19, 2026
Remote friendly (Florham Park, NJ)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development. Assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs.
Responsibilities:
- Responsible for product(s) and supports manager and/or Global Regulatory Lead (GRL) in development and execution of regulatory strategy (moderate impact to business activities and operations).
- Serves as Health Authority (HA) liaison; interfaces with FDA; coordinates preparation and completion of FDA meeting briefing packages and responses.
- Advises internal customers on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiates and makes decisions for project issues with cross-functional impact.
- May assist in training junior staff.
- Prepares and reviews regulatory submissions; ensures complete and timely responses to Health Authorities during application review.
- Supports regulatory submission and approval process; applies regulatory/technical knowledge across therapeutic areas.
- Recommends and implements changes to difficult projects based on interpretation of US/Canada regulations, guidances, and corporate policies.
- Presents pertinent regulatory information to cross-functional areas.
- Operates in compliance with regulations and guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Significant Work Activity: Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hour day).
Qualifications:
- Advanced degree (PharmD/PhD/MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry experience.
- Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem-solving, and consensus-building skills.
- Effective written and oral communication across and within Regulatory.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience in a complex, matrix environment.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.
Responsibilities:
- Responsible for product(s) and supports manager and/or Global Regulatory Lead (GRL) in development and execution of regulatory strategy (moderate impact to business activities and operations).
- Serves as Health Authority (HA) liaison; interfaces with FDA; coordinates preparation and completion of FDA meeting briefing packages and responses.
- Advises internal customers on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiates and makes decisions for project issues with cross-functional impact.
- May assist in training junior staff.
- Prepares and reviews regulatory submissions; ensures complete and timely responses to Health Authorities during application review.
- Supports regulatory submission and approval process; applies regulatory/technical knowledge across therapeutic areas.
- Recommends and implements changes to difficult projects based on interpretation of US/Canada regulations, guidances, and corporate policies.
- Presents pertinent regulatory information to cross-functional areas.
- Operates in compliance with regulations and guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Significant Work Activity: Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hour day).
Qualifications:
- Advanced degree (PharmD/PhD/MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry experience.
- Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem-solving, and consensus-building skills.
- Effective written and oral communication across and within Regulatory.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience in a complex, matrix environment.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.